A Randomized Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel)
Phase 2/Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Chemotherapy-induced Neutropenia
Both
Chemotherapy-induced Neutropenia
Trial Information
A Randomized Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel)
Inclusion Criteria:
- Breast cancer patients scheduled to receive the AT regimen (doxorubicin/ docetaxel).
Exclusion Criteria:
- Subjects may have received no more than 1 prior chemotherapy regimen (including
adjuvant therapy if given within the last 12 months).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Duration of severe neutropenia
Outcome Time Frame:
Cycle 1
Safety Issue:
No
Authority:
Russia: Ministry of Health of the Russian Federation
Study ID:
NEUGR-002
NCT ID:
NCT00837265
Start Date:
August 2008
Completion Date:
July 2010
Related Keywords:
- Chemotherapy-Induced Neutropenia
- Breast Cancer Supportive Care Neutropenia
- Breast Neoplasms
- Neutropenia
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